GMP auditing of Pharmaceutical Quality Management System

Client Type:  Regulatory Inspections, GxP System

Jurisdiction(s): Canada

Services Provided: Reviewed and established all regulatory, quality and compliance and validation procedures. Reviewed and ascertained any new regulatory requirements, commitments from Health Canada, and the client. Reviewed and studies technical reports in support of compliance. Performed on-site facility visits to conduct an audit and review raw data, reports, records, procedures, instructions, manuals, diagrams, and log books pertinent to the project. Prepared summaries and provided feedback on recommendations for remedial action.